Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 1, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 73%.

  • Purpose

    Antiseptic

  • Use

    Reduces bacteria on skin. Use when soap and water are not available.

  • Warnings

    Flammable. Keep away from flame.

  • Purpose

    For external use only. If swallowed, seek medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Do Not Use

    Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if rash appears.

  • Directions

    Bend where indicated on package to dispense. Squeeze contents into hands and rub together until dry.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Glycerin, Hydroxypropyl Cellulose

  • Package Label - Principal Display Panel

    Just Hand Sanitizer Box

    Just Hand Sanitizer box

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78065-2020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.876 mL  in 1.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.03 mL  in 1.2 mL
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 0.013 mL  in 1.2 mL
    WATER (UNII: 059QF0KO0R) 0.277 mL  in 1.2 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78065-2020-2100 in 1 BOX06/01/2020
    11.2 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:78065-2020-11.2 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/21/2020
    Labeler - STUDIO 320 (066376564)
    Registrant - Open Book Extracts (117239295)
    Establishment
    NameAddressID/FEIBusiness Operations
    Open Book Extracts117239295manufacture(78065-2020)
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